NCT03275129

Brief Summary

The investigators would like to investigate whether performing ultrasound assessments in patients undergoing surgery for hip fractures is able to identify previously undiagnosed heart or lung conditions. The investigators would like to determine whether information provided by this ultrasound assessment is significant enough to alter the anesthetic management plan of these patients. This study has the potential to demonstrate that ultrasound could be used as a diagnostic bedside tool in the perioperative period, possibly altering standard of care for this patient population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 7, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

May 28, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2021

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

3.5 years

First QC Date

August 24, 2017

Last Update Submit

April 16, 2022

Conditions

Keywords

ultrasound assessment

Outcome Measures

Primary Outcomes (1)

  • Changes of anesthesiologists' intraoperative management

    Changes of anaesthetic management include any changes in postpone of surgery (Y/N), modes of anesthesia (Y/N), uses of EKG (Y/N), arterial line (Y/N), fluid bolus (Y/N), liberal or restrictive fluid management (Y/N), central venous catherization (Y/N), and inotropic uses.

    During surgery

Secondary Outcomes (2)

  • Length of hospital stay

    Time to discharge, an average of 2 days

  • Postoperative complications

    Time to discharge, an average of 2 days

Study Arms (1)

Ultrasound assessment of heart and lungs

EXPERIMENTAL

Patients (over the age of 18) who will be undergoing surgery for hip fracture repair. These patients will receive an ultrasound of the heart and lungs to determine whether or not information gained from this ultrasound assessment is significant enough to influence their anesthetic care plan.

Diagnostic Test: Ultrasound assessment of heart and lungs

Interventions

Patients will receive an ultrasound assessment of their heart and lungs.

Ultrasound assessment of heart and lungs

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing urgent surgery for hip fractures

You may not qualify if:

  • under the age of 18 - patients who have a known heart or lung condition that mandates the anesthetic plan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LHSC - University Hospital

London, Ontario, N6A 5W9, Canada

Location

Related Publications (9)

  • Kline JP. Ultrasound guidance in anesthesia. AANA J. 2011 Jun;79(3):209-17.

    PMID: 21751689BACKGROUND
  • Espinet A, Dunning J. Does ultrasound-guided central line insertion reduce complications and time to placement in elective patients undergoing cardiac surgery. Interact Cardiovasc Thorac Surg. 2004 Sep;3(3):523-7. doi: 10.1016/j.icvts.2004.05.006.

    PMID: 17670301BACKGROUND
  • Guidance on the Use of Ultrasound Locating Devices for Placing Central Venous Catheters. NICE Guideline, 2002.

    BACKGROUND
  • Merchant R, Chartrand D, Dain S, Dobson G, Kurrek MM, Lagace A, Stacey S, Thiessen B; Canadian Anesthesiologists' Society. Guidelines to the practice of anesthesia--revised edition 2015. Can J Anaesth. 2015 Jan;62(1):54-67. doi: 10.1007/s12630-014-0232-8.

    PMID: 25323121BACKGROUND
  • Matava C, Hayes J. A survey of ultrasound use by academic and community anesthesiologists in Ontario. Can J Anaesth. 2011 Oct;58(10):929-35. doi: 10.1007/s12630-011-9555-x. Epub 2011 Jul 12.

    PMID: 21748662BACKGROUND
  • Zanobetti M, Coppa A, Nazerian P, Grifoni S, Scorpiniti M, Innocenti F, Conti A, Bigiarini S, Gualtieri S, Casula C, Ticali PF, Pini R. Chest Abdominal-Focused Assessment Sonography for Trauma during the primary survey in the Emergency Department: the CA-FAST protocol. Eur J Trauma Emerg Surg. 2018 Dec;44(6):805-810. doi: 10.1007/s00068-015-0620-y. Epub 2015 Dec 18.

    PMID: 26683569BACKGROUND
  • Markin NW, Gmelch BS, Griffee MJ, Holmberg TJ, Morgan DE, Zimmerman JM. A review of 364 perioperative rescue echocardiograms: findings of an anesthesiologist-staffed perioperative echocardiography service. J Cardiothorac Vasc Anesth. 2015 Feb;29(1):82-8. doi: 10.1053/j.jvca.2014.07.004. Epub 2014 Nov 7.

    PMID: 25440641BACKGROUND
  • Soong C, Cram P, Chezar K, Tajammal F, Exconde K, Matelski J, Sinha SK, Abrams HB, Fan-Lun C, Fabbruzzo-Cota C, Backstein D, Bell CM. Impact of an Integrated Hip Fracture Inpatient Program on Length of Stay and Costs. J Orthop Trauma. 2016 Dec;30(12):647-652. doi: 10.1097/BOT.0000000000000691.

    PMID: 27875490BACKGROUND
  • Chui J, Hegazy AF, German M, Arango-Ferreira C, Fochesato LA, Lavi R, Bainbridge D. Point-of-care lung and cardiac ultrasound (LUCAS) study in hip fracture patients: a prospective cohort study. Can J Anaesth. 2023 Sep;70(9):1474-1485. doi: 10.1007/s12630-023-02511-5. Epub 2023 Jun 21.

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Jason Chui

    University of Western Ontario, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Patients over the age of 18 who arrive to the hospital requiring surgery for hip fracture repair.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Anesthesiologist

Study Record Dates

First Submitted

August 24, 2017

First Posted

September 7, 2017

Study Start

May 28, 2018

Primary Completion

November 30, 2021

Study Completion

December 11, 2021

Last Updated

April 19, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations